Vanda Pharmaceuticals Announces Initiation of The Thetis Study, a Clinical Trial of NEREUS™ for the Prevention of Vomiting Induced by GLP-1 Receptor Agonists
Rhea-AI Summary
Vanda Pharmaceuticals (Nasdaq: VNDA) initiated Thetis, a multicenter, randomized, double-blind Phase 2 trial of NEREUS™ (tradipitant) to prevent vomiting in patients started on high-dose GLP-1 receptor agonists. The company expects topline results by Q4 2026.
Prior Phase 2 data showed vomiting in 29.3% of tradipitant-treated participants versus 58.6% on placebo (p=0.0016), a 50% relative reduction; a key secondary endpoint also favored tradipitant (22.4% vs 48.3%, p=0.0039).
Positive
- Phase 2 success: 50% relative reduction in vomiting (tradipitant vs placebo)
- Topline timeline: Thetis results expected by Q4 2026
- Regulatory foothold: NEREUS approved for motion-induced vomiting
Negative
- Residual vomiting: 29.3% of tradipitant-treated participants still vomited
- NDA uncertainty: Additional study data may be required before NDA submission
News Market Reaction – VNDA
In the Apr 9 session, VNDA gained 0.55%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jan 08 | FDA decision letter | Negative | -14.1% | FDA concluded HETLIOZ® jet lag sNDA cannot be approved in current form. |
| Nov 05 | Conference participation | Neutral | -0.7% | Company participation and presentation at Stifel 2025 Healthcare Conference. |
| Oct 08 | Brand partnership | Positive | +2.7% | Multi‑year Founding Partner deal with Monumental Sports & Entertainment for arena branding. |
| Oct 01 | FDA dispute framework | Positive | +1.2% | Collaborative framework with FDA to resolve multiple disputes on HETLIOZ® and tradipitant. |
| Sep 25 | Insomnia trial data | Positive | -1.4% | Publication of positive HETLIOZ® insomnia trial results in PLOS One journal. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical-trial-tagged headlines for VNDA have shown mixed reactions, with an average move of -2.45% and both strong selloffs on negative FDA decisions and modest gains on collaborative/regulatory progress.
Recent clinical‑trial‑tagged news for Vanda spans regulatory friction and progress with the FDA as well as broader visibility efforts. In Jan 2026, an FDA letter stating HETLIOZ® “cannot be approved in its current form” saw shares fall 14.05%. Earlier, a collaborative framework with the FDA on HETLIOZ® and tradipitant in Oct 2025 and positive insomnia trial data drove smaller moves. Against this backdrop, the NEREUS™ GLP‑1 vomiting prevention program extends Vanda’s clinical footprint beyond sleep and jet lag.
Key Terms
glucagon-like peptide-1 (glp-1) receptor agonist therapies medical
semaglutide medical
tirzepatide medical
randomized, double-blind, placebo-controlled technical
phase 2 study medical
p=0.0016 technical
p=0.0039 technical
new drug application (nda) regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
GLP-1 receptor agonists, including semaglutide and tirzepatide, have transformed the treatment of type 2 diabetes and obesity. However, gastrointestinal side effects, particularly nausea and vomiting, remain a significant challenge for many patients and are a leading cause of treatment discontinuation or dose reduction. Recent studies and approvals in the GLP-1 space further underscore this. Last month, a "high dose" of Wegovy was approved by the
"GLP-1 receptor agonists offer significant benefits, but vomiting and nausea can severely impact patient adherence and quality of life," said Mihael H. Polymeropoulos, M.D., President CEO and Chairman of the Board of Vanda Pharmaceuticals. "NEREUS™ has demonstrated potent antiemetic effects in prior clinical studies. We are excited to advance this program, which has the potential to improve tolerability and allow more patients to fully benefit from these important therapies."
The Thetis study is a multicenter, randomized, double-blind, placebo-controlled trial that will evaluate the efficacy and safety of oral tradipitant in patients initiated at a high dose of a GLP-1 receptor agonist. The primary endpoint is the proportion of patients free from vomiting episodes during the treatment period.
The Phase 2 study, as previously announced in Vanda's press release dated November 15, 2025, was similar in design where patients were pre-treated with either tradipitant or placebo before administering a 1 mg injection of Wegovy®, a dose that normally takes 9 weeks of titration to reach. The phase 2 study succeeded and met its primary endpoint, with only
Vanda expects topline results from the Thetis study by Q4 2026. Following completion of the Thetis study, additional study data may be required prior to approval of a New Drug Application (NDA).
References
- See full
U.S. NEREUS Prescribing Information, available at: www.nereus.us. - See full
U.S. Wegovy Prescribing Information, available at: https://www.novo-pi.com/wegovy.pdf. - See Vanda Pharmaceuticals Reports Positive Results for Tradipitant in Preventing GLP-1 Induced Nausea and Vomiting, available at: https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-positive-results-for-tradipitant-in-preventing-glp-1-induced-nausea-and-vomiting-302617739.html.
About NEREUS™
NEREUS™ (tradipitant) is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company. NEREUS™ is approved for the acute prevention of vomiting induced by motion in adults, and is currently in clinical development for a variety of indications, including gastroparesis and the prevention of nausea and vomiting induced by GLP-1 receptor agonists. Full NEREUS™ Prescribing Information can be found at: https://www.nereus.us.
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this press release, including, but not limited to, statements regarding the design, objectives and potential outcomes of the Thetis clinical trial; the potential benefits, effectiveness and safety of NEREUS™ (tradipitant) for the prevention of vomiting in patients receiving GLP‑1 receptor agonist therapies; the significance of results from prior clinical studies; the expected timing of topline results from the Thetis study; and the risk that additional study data may be required prior to approval of an NDA, are "forward‑looking statements" within the meaning of the securities laws. All statements other than statements of historical fact are statements that could be deemed forward‑looking statements. Forward‑looking statements are based on current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, risks inherent in clinical development, including the risk that the Thetis trial may not demonstrate efficacy or safety consistent with prior studies, may not meet its primary or secondary endpoints, or may experience delays; variability in patient response to therapy; regulatory considerations affecting the development of NEREUS™ for additional indications; and the risk that additional study data may be required prior to approval of an NDA. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward‑looking statements in this press release should be evaluated together with the risks and uncertainties described in the sections titled "Cautionary Note Regarding Forward‑Looking Statements," "Risk Factors," and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Vanda's most recent Annual Report on Form 10‑K, as updated by Vanda's subsequent Quarterly Reports on Form 10‑Q, Current Reports on Form 8‑K, and other filings with the
All forward‑looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth herein. Vanda cautions investors not to place undue reliance on forward‑looking statements. The information contained in this press release is provided as of the date hereof, and Vanda undertakes no obligation, and expressly disclaims any obligation, to update or revise any forward‑looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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Collected Strategies
VANDA-CS@collectedstrategies.com
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SOURCE Vanda Pharmaceuticals Inc.